Author Interviews, Biomarkers, Cancer Research, JAMA / 29.12.2016

MedicalResearch.com Interview with David A Mankoff, MD, PhD Gerd Muehllehner Professor of Radiology Attending Physician University of Pennsylvania Health System PET Center Director Vice-Chair of Research, Department of Radiology University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: This review was designed to describe the current status of molecular imaging, especially positron emission tomography (PET) as a clinical tool for helping to direct precision oncology. We found that while there had been a number of promising methods tested in small, single research studies, the number of new molecular imaging tests translated to the clinic was small. In addition, the application of molecular methods as tools for therapeutic decision making (versus use for disease detections and staging) was even smaller. We noted that some recently published studies, including a few large multi-center trials, indicated the considerable potential of new molecular imaging tests to identify therapeutic targets for cancer treatment, to evaluate early response to targeted cancer therapy, and to predict downstream outcomes such as progression free survival. We made some observations and recommendations in the review for directing these potentially powerful imaging tools towards use as biomarkers for precision oncology. (more…)
Author Interviews, Diabetes, Heart Disease, JAMA, Lipids / 29.12.2016

MedicalResearch.com Interview with: Marshall B. Elam PhD MD Professor Pharmacology and Medicine (Cardiovascular Diseases) University of Tennessee Health Sciences Center Memphis MedicalResearch.com: What is the background for this study? What are the main findings? Response: This manuscript presents the findings of extended follow up of patients with Type 2 Diabetes who were treated with fenofibrate, a member of a group of triglyceride lowering medications known as fibrates or PPAR alpha agonists, as part of the Action to Control Cardiovascular Risk in T2DM (ACCORD) study. ACCORD was designed to test the effect of intensive treatment of cardiovascular risk factors including blood glucose, blood pressure and lipids on risk of heart attack, stroke and cardiac death in patients with Type 2 Diabetes. The lipid arm of ACCORD tested the hypothesis that adding fenofibrate to statin therapy would further reduce risk of these cardiovascular events. (more…)
Author Interviews, Cost of Health Care, Critical Care - Intensive Care - ICUs, JAMA / 27.12.2016

MedicalResearch.com Interview with: Dr. Dong W. Chang, MD MS Division of Respiratory and Critical Care Physiology and Medicine Los Angeles Biomed Research Institute at Harbor-University of California Los Angeles, Medical Center Torrance California MedicalResearch.com: What is the background for this study? Response: The study was based on our overall impression that ICU care is often delivered to patients who are unlikely to derive long-term benefit (based on their co-morbidities/severity of illness, etc.). However, what surprised us was the magnitude of this problem. Our study found more than half the patients in ICU at a major metropolitan acute-care hospital could have been cared for in less expensive and invasive settings. (more…)
Author Interviews, Hospital Readmissions, JAMA, Yale / 27.12.2016

MedicalResearch.com Interview with: Nihar R. Desai, MD, MPH Assistant Professor of Medicine Section of Cardiovascular Medicine, Yale School of Medicine Center for Outcomes Research and Evaluation Yale New Haven Health System MedicalResearch.com: What is the background for this study? Response: Reducing rates of readmissions after hospitalization has been a major focus for patients, providers, payers, and policymakers because they reflect, at least partially, the quality of care and care transitions, and account for substantial costs. The Hospital Readmission Reduction Program (HRRP) was enacted under Section 3025 of the Patient Protection and Affordable Care Act (ACA) in March 2010 and imposed financial penalties beginning in October 2012 for hospitals with higher than expected readmissions for acute myocardial infarction (AMI), congestive heart failure (HF), and pneumonia among their fee-for-service Medicare beneficiaries. In recent years, readmission rates have fallen nationally, and for both target (AMI, HF, pneumonia) and non-target conditions. We were interested in determining whether the Hospital Readmission Reduction Program (HRRP) associated with different changes in readmission rates for targeted and non-targeted conditions for penalized vs non-penalized hospitals? (more…)
Author Interviews, Herpes Viruses, JAMA / 22.12.2016

MedicalResearch.com Interview with:   MedicalResearch.com: What is the background for this study?  What are the main findings? Genital herpes is a sexually transmitted infection that is caused by one of two subtypes of the herpes simplex virus (HSV-1 and HSV-2). The condition is common in the United States, as the CDC estimates that almost one in six people between the ages of 14 and 49 are afflicted. Unfortunately, there are no good screening tests for herpes and it cannot be cured. After a systematic review of the evidence, the U.S. Preventive Services Task Force determined that, for adolescents and adults who have no signs or symptoms, including pregnant women, the harms of screening for genital herpes outweigh the benefits. These harms include high rates of false-positive screening tests, potential concerns around unnecessary antiviral medication use, and anxiety and relationship issues related to diagnosis. Additionally, the benefits of screening proved small, in part because early identification and treatment do not alter the course of the condition. In the end, due to the lack of benefits in the face of serious harms, the Task Force recommended against routine serologic screening for genital herpes simplex virus (HSV) infection. (more…)
Author Interviews, Brain Injury, JAMA, Pediatrics / 21.12.2016

MedicalResearch.com Interview with: Roger Zemek, MD, FRCPC Associate Professor, Dept of Pediatrics and Emergency Medicine, Clinical Research Chair in Pediatric Concussion, University of Ottawa Director, Clinical Research Unit, Children’s Hospital of Eastern Ontario Ottawa, ON MedicalResearch.com: What is the background for this study? Response: While current concussion protocols endorse the conservative view that children should avoid physical activity until completely symptom-free, there is little evidence beyond expert opinion regarding the ideal timing of physical activity re-introduction. In fact, while rest does play a role in concussion recovery, protracted physical rest may actually negatively impact concussion recovery. Further, physiological, psychological, and functional benefits of early physical rehabilitation are observed in other disease processes such as stroke (which is an example of a severe traumatic brain injury). Therefore, our objective was to investigate the relationship between early physical activity (defined within 7 days of the concussion) and the eventual development of persistent post-concussion symptoms at one month. (more…)
Author Interviews, JAMA, Pediatrics / 21.12.2016

MedicalResearch.com Interview with: Eyal Cohen, MD, MSc, FRCP(C) Staff Physician, Paediatrics The Hospital for Sick Children Associate Scientist, Research Institute Child Health Evaluative Sciences Associate Professor, University of Toronto   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Major structural or genetic congenital anomalies affect approximately 2 percent to 5 percent of all births in the United States and Europe. Mothers of children born with major congenital anomalies face serious challenges such as high financial pressures, as well as the burden of providing care to a child with complex needs within the home setting, which can impair a mother's health. Little is known about the long-term health consequences for the mother. We assessed whether the birth of an infant with a major congenital anomaly was subsequently associated with an increased risk of death of the infant's mother. The population-based study (n = 455,250 women) used individual-level linked Danish registry data for mothers who gave birth to an infant with a major congenital anomaly between 1979 and 2010, with follow-up until December 31, 2014. A comparison group was constructed by randomly sampling, for each mother with an affected infant, up to 10 mothers matched on maternal age, parity (the number of children a woman has given birth to), and year of infant's birth. Mothers in both groups were an average age of 29 years at delivery. After a median follow-up of 21 years, there were 1,275 deaths (1.60 per 1,000 person-years) among 41,508 mothers of a child with a major congenital anomaly vs 10,112 deaths (1.27 per 1,000 person-years) among 413,742 mothers in the comparison group. Mothers with affected infants were more likely to die of cardiovascular disease, respiratory disease, and other natural causes. (more…)
Author Interviews, Brigham & Women's - Harvard, Gender Differences, Hospital Readmissions, JAMA / 20.12.2016

MedicalResearch.com Interview with: Yusuke Tsugawa, MD, MPH, PhD Department of Health Policy and Management Harvard T. H. Chan School of Public Health, Department of Medicine Brigham and Women’s Hospital and Harvard Medical School Boston, Massachusetts  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We analyzed a 20% sample of Medicare beneficiaries hospitalized with a medical condition in 2011-2014, and found that patients treated by female doctors have lower mortality and readmission rates than those cared for by male doctors. (more…)
Author Interviews, Genetic Research, JAMA / 16.12.2016

MedicalResearch.com Interview with: C. Anthony Blau, M.D. Professor of Medicine, Division of Hematology University of Washington School of Medicine Co-Director, University of Washington Institute for Stem Cell and Regenerative Medicine Director, Center for Cancer Innovation MedicalResearch.com: What is the background for this study? What are the main findings? Response: Matching cancer treatment to the molecular composition of a patient’s tumor holds promise for making cancer therapies more effective, and molecular testing for cancer patients has become widespread in recent years. Recently molecular testing of tumor samples has been complemented by blood tests that characterize tumor DNA that has been shed into the bloodstream.  Blood tests are attractive because they are much less invasive than obtaining tumor tissue via biopsies. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pediatrics, Pulmonary Disease / 15.12.2016

MedicalResearch.com Interview with: Kristin N. Ferguson, BSc The Royal Women’s Hospital and Deakin University Melbourne, Victoria, Australia MedicalResearch.com: What is the background for this study? Response: Weaning preterm infants from mechanical ventilation, thereby minimising the risks of having an endotracheal tube in situ which may further damage their fragile lungs, is something all neonatal clinicians are keen to do. We provide clinicians with a straightforward list of safe and effective strategies to help them in this task, as well as pointing out some treatments to either avoid or use with caution. (more…)
Author Interviews, Education, JAMA, Surgical Research / 15.12.2016

MedicalResearch.com Interview with: Mohammed Al-Omran, MD, MSc, FRCSC Head, Division of Vascular Surgery St. Michael’s Hospital Professor, Department of Surgery University of Toronto MedicalResearch.com: What is the background for this study? What are the main findings? Response: General surgery residency is among the most demanding clinical training programs in medicine. Several studies have suggested surgical residents have a relatively high attrition rate; however, no study has systematically reviewed the overall prevalence and causes of attrition among general surgery residents. We included over 20 studies representing 19,821 general surgery residents in our review. Most studies were from the US. We found the pooled estimate of attrition prevalence among general surgery residents was 18%. Female residents were more likely to leave than male (25% versus 15%), and residents were most likely to leave after their first training year (48%). Departing residents most commonly switched to another medical specialty (such as anaesthesia, plastic surgery, radiology or family medicine) or relocated to another general surgery program. The most common causes of attrition were uncontrollable lifestyle (range of 18% to 88%) and transferring to another specialty (range of 18% to 39%). (more…)
Author Interviews, Dermatology, Education, JAMA, Melanoma / 15.12.2016

MedicalResearch.com Interview with: June K. Robinson, MD Research Professor of Dermatology Northwestern University Feinberg School of Medicine Department of Dermatology Chicago, IL 60611 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This is a secondary finding from a randomized controlled trial of a structured skills training program for melanoma patients and their skin check partners. The pairs learned and performed skin self-examination for the early detection of melanoma. They continued to perform skin checks for 2 years and trained pairs identified more early melanoma (melanoma in situ and Stage 1A melanoma) than controls. (more…)
Author Interviews, Education, JAMA, Outcomes & Safety, UCSF / 12.12.2016

MedicalResearch.com Interview with: Charlie M. Wray, DO, MS Assistant Clinical Professor of Medicine University of California, San Francisco Department of Medicine San Francisco VA Medical Center MedicalResearch.com: What is the background for this study? Response: Since the establishment of residency duty hour regulations in 2010, which subsequently lead to increased discontinuity of inpatient care and more resident shift work, educators and researchers have attempted to establish which shift handoff technique(s) or strategies work best. National organizations, such as the ACGME, AHRQ, and the Joint Commission have made specific recommendations that are considered "best practice". In our study, using an annual national survey given to Internal Medicine Program Directors, we examined the degree of implementation of these recommended handoff strategies and the proportion of Program Director satisfaction with each of the respective strategies. (more…)
Author Interviews, Breast Cancer, Genetic Research, JAMA / 12.12.2016

MedicalResearch.com Interview with: Dr. Adrian Lee PhD Professor, Department of Pharmacology and Chemical Biology Director, Women's Cancer Research Center University of Pittsburgh Cancer Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: The goal of this study was to understand molecular changes which occur when breast cancers metastasize to the brain, with the eventual of identifying new therapeutic strategies. Brain metastases occur in 10-15% of patients with metastatic breast cancer and are a major clinical challenge. Limited therapeutic options exist for patients with brain metastases. We analyzed molecular changes in pairs of patient-matched primary breast cancers and brain metastases. We found that brain metastases tended to have the same intrinsic subtype as the primary breast cancer, however, there were many genes which changes in gene expression and may represent therapeutic targets. The most common change was an increase in ErbB2/HER2 which can be targeted clinically. (more…)
Author Interviews, Biomarkers, Infections, JAMA, Neurological Disorders / 12.12.2016

MedicalResearch.com Interview with: Zanusso Gianluigi M.D.Ph.D. Department of Neurosciences, Biomedicine and Movement Sciences University of Verona Verona, Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: To determine RT-QuIC assay sensitivity and specificity in cerebrospinal fluid and olfactory mucosa in a large group of patients with a clinical diagnosis of probable, possible or suspect Creutzfeldt–Jakob disease (CJD) and controls. In these patients, RT-QuIC testing of CSF and olfactory mucosa provided a specificity and sensitivity of 100%. A softer swab for olfactory mucosa sampling provided the same sensitivity as using a brush . (more…)
Author Interviews, Education, JAMA, Outcomes & Safety / 09.12.2016

MedicalResearch.com Interview with: Joshua L Denson MD Pulmonary and Critical Care Medicine University of Colorado School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Miscommunication during physician transition in care has been associated with adverse patient events and medical errors; however, an understudied topic is the transition in care that occurs each month when resident physicians switch clinical rotations, also called an end-of-rotation transition. During this handoff, hospitalized patients (up to 10-20) are handed over to an oncoming physician who has never met the patients. We sought to investigate if this type of transition was associated with worse patient outcomes, specifically mortality. On July 1, 2011, the Accreditation Council for Graduate Medical Education (ACGME) duty-hour regulations limited first-year resident physicians (interns) to 16 continuous hours of work. Although these rules do not appear to have affected overall patient safety outcomes, they have been associated with an increase in shift-to-shift handoffs among training physicians. Given this, we wanted to study how they might impact patient outcomes surrounding end-of-rotation transitions in care. (more…)
Author Interviews, Depression, JAMA, McGill, Pharmacology, Stroke / 09.12.2016

MedicalResearch.com Interview with: Christel Renoux, MD, PhD Assistant Professor, Dept. of Neurology & Neurosurgery McGill University Centre For Clinical Epidemiology Jewish General Hospital - Lady Davis Research Institute Montreal  Canada MedicalResearch.com: What is the background for this study? Response: Selective serotonin reuptake inhibitors (SSRIs) increase the risk for abnormal bleeding, in particular, gastrointestinal tract bleeding. Previous studies also suggested an increased risk for intracranial hemorrhage (ICH) in patients treated with SSRIs compared to non users. However, even if this risk exists, the comparison with a non-treated group may exaggerate the strength of a potential association and the comparison with a group of patients treated with other antidepressants may help better delineate the risk. The potential bleeding effect of antidepressants is linked to the strength of serotonin inhibition reuptake, and antidepressants that are strong inhibitors of serotonin reuptake have been associated with the risk for gastrointestinal or abnormal bleeding compared with weak inhibitors but the risk of ICH is unclear. (more…)
Aging, Author Interviews, Genetic Research, JAMA, Macular Degeneration, Ophthalmology / 08.12.2016

MedicalResearch.com Interview with: dr-anneke-i-den-hollanderAnneke I. den Hollander, PhD Department of Ophthalmology and Department of Human Genetics Donders Institute for Brain, Cognition, and Behaviour Radboud University Medical Center Nijmegen, the Netherland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Age-related macular degeneration is caused by a combination of genetic and environmental factors. Rare genetic variants in the complement system have been described in AMD, but their effect remains largely unexplored. In this study we aimed to determine the effect of rare genetic variants in the complement system on complement levels and activity in serum. MedicalResearch.com: What are the main findings? Response: Carriers of CFI variants showed decreased FI levels, carriers of C9 Pro167Ser had increased C9 levels, while C3 and FH levels were not altered. Carriers of CFH and CFI variants had a reduced ability to degrade C3b, which for CFI was linked to reduced serum FI levels. (more…)
Author Interviews, Dermatology, Electronic Records, JAMA, Outcomes & Safety, Surgical Research / 08.12.2016

MedicalResearch.com Interview with: Sophia Akhiyat M.D. Candidate, Class of 2017 The George Washington University School of Medicine and Health Sciences METEOR Fellowship MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study was inspired by one of Choudhry et al,1 in which patients' preferences for skin biopsy result disclosure was surveyed at melanoma clinics affiliated with several academic institutions. We sought to broaden participant inclusion criteria by evaluating patients' preferences at a general dermatology clinic at an academic center. Our findings support that the highest ranked patient-preferred method for receiving skin biopsy results was through an online portal. Patients also reported that the most important factors when selecting a modality for communication were the amount of information given and time available to discuss results. We also observed a relationship between a younger patient age range and online portal experience as well as a preference for biopsy notification via online portal. 1Choudhry A, Hong J, Chong K, et al. Patients' Preferences for Biopsy Result Notification in an Era of Electronic Messaging Methods. JAMA Dermatol. 2015;151(5):513-521. (more…)
ADHD, Author Interviews, Education, JAMA, UCSF / 08.12.2016

MedicalResearch.com Interview with:  

Lisa Meeks , PhD Director, Medical Student Disability UCSF Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings? Response: This was the first study to include students with AD/HD, learning, psychological, and chronic health conditions. This study found that the prevalence of students with disabilities is up to four times higher than previous studies indicated.

AD/HD, learning, and psychological disabilities were the most prevalent, suggesting that most students with disabilities in medicine have non-apparent disabilities. Within MD granting programs, the number of students self-reporting disability varied between 0% and 12%. Explanations for the high variability between programs are unknown, however, anecdotal reports suggest the degree to which programs have dedicated resources and inclusive practices for students with disabilities influence student disclosure. (more…)
Author Interviews, Dermatology, JAMA, Pediatrics / 07.12.2016

MedicalResearch.com Interview with: Steve Xu MD, MSc Resident Physician Department of Dermatology Northwestern Feinberg School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Given the limited data on the effectiveness or safety of the different moisturizers examined in the study, how much do you think parents should decide what to use on their babies based on the "cost-effectiveness" determined in this study? Would you just say cheapest is best since we don't know how well these things work? Or what's the message? Price. Petrolatum is an extremely effective moisturizer. It also happens to be one of the most affordable. Unlike adults, I don't suspect newborns will complain too much about the greasiness of petrolatum. They're less concerned that their work clothes will get ruined. They are less likely to care about cosmetic elegance. I also will say that petrolatum is less likely to include any artificial fragrances, preservatives that could serve as irritants or allergens in the future. That's an added bonus. (more…)
Author Interviews, Education, JAMA / 06.12.2016

MedicalResearch.com Interview with: Karen E. Hauer, MD, PhD Associate Dean, Competency Assessment and Professional Standards Professor of Medicine, UCSF San Francisco, CA  94143 MedicalResearch.com: What is the background for this study? Response: As part of the Accreditation Council for Graduate Medical Education (ACGME)’s Next Accreditation System, residency programs are now required to rate residents using the Milestones. Evidence of validity of Milestone ratings is needed to show whether this rating system measures meaningful aspects of residents’ practice. In the field of internal medicine, we compared ratings of residents using the old evaluation form, the pre-2015 Resident Annual Evaluation Summary (RAES), which has a non-developmental rating scale that rates residents from unsatisfactory to superior on a 9-point scale, with developmental Milestone ratings. This was a cross-sectional study of all United States internal medicine residency programs in 2013-14, including 21,284 internal medicine residents. Milestone ratings are submitted by residency program directors working with Clinical Competency Committees. We correlated RAES and Milestone ratings by training year; correlated ratings of Medical Knowledge milestones using the two systems with American Board of Internal Medicine (ABIM) certification examination scores; and examined ratings of unprofessional behavior using the two systems. (more…)
Aging, Author Interviews, Cancer Research, Global Health, JAMA / 06.12.2016

MedicalResearch.com Interview with: Christina Fitzmaurice, MD, MPH Assistant Professor Department of Medicine, Division of Hematology Institute for Health Metrics and Evaluation University of Washington Seattle, WA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cancer is the second leading cause of death worldwide behind cardiovascular diseases. We found that cancer cases increased by 33% from 13.1 million cases in 2005 to 17.5 million in 2015. The largest driver behind this increase was an aging population, followed by a growing population worldwide. The smallest factor contributing to this increase was a rise in cancer incidence rates. Because of increasing life expectancy and better control of communicable diseases cancer will remain a major burden in the foreseeable future. Adjusting and building health systems that can appropriately deal with this challenge is only possible with good data on the burden of cancer. In our study we estimate the number of cancer cases, and cancer deaths over time for 32 cancers in 195 countries and territories from 1990 to 2015. We also estimate how many years of life were lost due to cancer as well as disability adjusted life years and a summary measure that combines these two into disability adjusted life years. (more…)
Author Interviews, Exercise - Fitness, Frailty, JAMA / 06.12.2016

MedicalResearch.com Interview with: Maayan Agmon, PhD The Cheryl Spencer Department of Nursing Faculty of Social Welfare and Health Studies University of Haifa Haifa, Israel MedicalResearch.com: What is the background for this study? What are the main findings? Response: To address the issue of functional decline during and post hospitalization . Up to 40% of older adults decline in their function at the time of hospitalization and acute illness. Most part of this functional decline is not explained by illness itself. So far, we know that in-hospital mobility is a protective factor but how much walking is required to prevent this decline has yet to be determined. (more…)
Author Interviews, Colon Cancer, JAMA / 03.12.2016

MedicalResearch.com Interview with: David Lieberman MD Professor of Medicine Chief, Division of Gastroenterology and Hepatology Oregon Health and Science University Portland, OR 97239 MedicalResearch.com: What is the background for this study? What are the main findings? Response: New guidelines for colorectal cancer (CRC) screening from the USPSTF were published in June 2016. They recommended any of 8 different screening programs. The purpose of this review was to highlight elements not included in the USPSTF report: 1. Elements of informed decision making associated with each program 2. Quality metrics for each program 3. Recommendations for higher than average risk individuals (more…)
Alzheimer's - Dementia, Author Interviews, Cognitive Issues, Depression, JAMA / 03.12.2016

MedicalResearch.com Interview with: Zahinoor Ismail MD FRCPC Clinical Associate Professor, Hotchkiss Brain Institute University of Calgary MedicalResearch.com: What is the background for this study? What are the main findings? Response: Depression and depressive symptoms are common in mild cognitive impairment (MCI). Evidence suggests that depression in MCI increases the likelihood of progression from MCI to dementia, compared to non-depressed people with MCI. In the newer construct of mild behavioural impairment (MBI), which describes the relationship between later life onset of sustained and impactful neuropsychiatric symptoms and the risk of cognitive decline and dementia, depression is an important subdomain (in addition to apathy, impulse control, social cognition and psychotic symptoms). Thus, depression and depressive symptoms are a significant risk factor for cognitive, behavioural and functional outcomes in older adults who have at most mild cognitive impairment. As the importance of neuropsychiatric symptoms in older adults emerges, good prevalence estimates are required to inform clinicians and researchers as well as public health policy and decision makers. We performed a systematic review and meta-analysis to determine the best estimate of prevalence of depression in  mild cognitive impairment. We included 57 studies, representing 20,892 participants in the analysis. While we determined that the omnibus prevalence estimate was 32%, there was significant heterogeneity in this sample based on setting. In community samples, the rate was 25%, but in clinical samples this was higher at 40%. Additionally, different case ascertainment methods for depression (self report, clinician administered or caregiver report) and different MCI criteria didn't change the prevalence estimates. (more…)
Author Interviews, FDA, JAMA, Ophthalmology / 02.12.2016

MedicalResearch.com Interview with: Malvina Eydelman, M.D. Division Director; Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health FDA. MedicalResearch.com: What is the background for this study? Response: In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK. The project aimed to develop a tool to determine the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients. At the time we developed our project, there was a limited amount of valid scientific data on certain patient-reported outcomes (PROs) related to LASIK. A PRO is a report of a condition experienced and reported by the patient, not the health care provider. Most LASIK studies used tools, such as questionnaires, to assess visual symptoms, but only after the surgery. The Patient-Reported Outcomes with LASIK (PROWL) studies in the LQOLCP assessed visual symptoms both before and after their LASIK surgery to identify changes over time. The studies also measured the impact symptoms directly had on performing usual activities, which had not previously been done. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Johns Hopkins / 02.12.2016

MedicalResearch.com Interview with: Dr. Amol K. Narang, MD Instructor of Radiation Oncology and Molecular Radiation Sciences Johns Hopkins Sidney Kimmel Comprehensive Cancer Center MedicalResearch.com: What is the background for this study? Response: We know that cancer care is becoming increasingly expensive in the U.S., but the financial impact on patients in the form of out-of-pocket expenses is not well understood, in part because of the lack of data sources that track this information. As such, we used the Health and Retirement study, a national panel study that closely tracks the out-of-pocket medical expenditures of older Americans, to understand the level of financial strain that Medicare patients experience after a new diagnosis of cancer. We further investigated what factors were associated with high financial strain and what type of health services were driving high costs in this population. (more…)